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Medical Ultrasound Gel
EUDAMEDClass I (EU MDR)
Ref 5KG TABRef 250g netural englishRef 4L livingstoneRef 5L MSL
Identity
- Trade Name
- Medical Ultrasound Gel EUDAMED
- Device Name
- Medical Ultrasound Gel EUDAMED
- Model / Reference
- 5KG TAB EUDAMED250g netural english EUDAMED4L livingstone EUDAMED5L MSL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950689130137 EUDAMED06950689130144 EUDAMED06950689130175 EUDAMED06950689130199 EUDAMED
- Basic UDI-DI
- 69506891GEL002LX EUDAMED
- EMDN Code
- Z12010885 INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMEDPoland EUDAMEDCyprus EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medical Ultrasound Gel by Shanghai Shenfeng Medical&Health Articles Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69506891GEL002LX | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Shenfeng Medical&Health Articles Co., Ltd
- EUDAMED SRN
- CN-MF-000012676
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 98c1b7c8-0b93-4bdb-a24f-a6214fda92b7 61 fields · synced Oct 6, 2026
- EUDAMED 3310f14b-dfe3-457a-bf60-ee94cd2385d9 61 fields · synced May 17, 2026
- EUDAMED 17fb0bc7-26ff-43a5-8da2-28a4d89f02a7 61 fields · synced May 17, 2026
- EUDAMED 296676ce-4c19-48b4-9919-e8d5d775fd6a 61 fields · synced May 18, 2026